Kornimate/medical-research-clean huggingface dataset:
comparison of two different optical biometric systems

Conditions: Cataract; Presbyopia; Ocular Biometry; Intraocular Lens

Summary: primary objective of this study is to evaluate and compare the measurements of two different optical biometrics systems in patients who will undergo cataract surgery or presbyopia surgery using intraocular lenses (iol-pc).

this is a prospective study including patients visiting the outpatient ophthalmology clinic of the university general hospital of alexandroupolis, who suffer from diagnosed cataract or presbyopia and are going to undergo implantation of intraocular lenses surgery. the patients will be fully informed about the procedure and the purpose of the study and a written informed consent will be provided by all participants. they will then undergo an ocular biometry examination using two optical biometric systems, argos (alcon laboratories, inc.) and iolmaster 500 (carl zeiss meditec ag). iol master 500 (carl zeiss meditec ag) is a non-invasive optical biometer that uses partial coherence interferometry (pci) with a wavelength of 780 nm to measure the al of the eye. argos (alcon laboratories, inc.) is a novel non-invasive optical biometer that uses swept source optical coherence tomography (ss-oct) with a wavelength of 1050 nm. the measurements of the two systems that will be compared are the axial length, the keratometry values, the anterior chamber depth (acd), the horizontal corneal diameter (white to white \[wtw\]) and the lens power in diopters (d).

Eligibility criteria:
inclusion criteria: * patients with cataract and/or presbyopia who will undergo intraocular lens implantation. exclusion criteria: * dense cataract that does not allow measurements to be taken with an optical biometrics system.

Keywords: cataract presbyopia argos iol master 500 optical biometric system
the efficacy and safety study of cb-5945 for the treatment of opioid-induced constipation

Conditions: Opioid-Induced Constipation

Summary: the purpose of this study is to evaluate the safety and efficacy of cb-5945 for the treatment of opioid-induced constipation (oic) in adults taking opioid therapy for chronic non-cancer pain.

this is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with oic taking opioid therapy for chronic non-cancer pain. approximately 600 participants (300 participants per treatment group) with oic will be randomized at approximately 75 study centers to receive either oral 0.25 mg cb-5945 bid or oral matching placebo bid for the 12-week double-blind treatment period, followed by a 4-week follow-up period. all randomized participants will be evaluated for clinical response for duration of their study participation. all participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. the clinical study report for this study includes pooled results for studies 5945-oic-12-02 (nct01901302) 5945-oic-12-03 (nct01901328), and 5945-oic-12-04 (nct01901341).

Eligibility criteria:
key inclusion criteria: * is taking a stable daily dose of opioids of ≥ 30 mg morphine equivalent total daily dose (metdd) for chronic non-cancer pain * has constipation that is caused by the chronic use of opioids * is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from screening until the last study assessment key exclusion criteria: * has gastrointestinal (gi) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction * has evidence of intestinal obstruction * has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening * has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled) * is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone) * is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)

Keywords: opioid constipation chronic pain
evaluation of the consequences of poly vaccination on innate immunity : applications to a military population

Conditions: Vaccine Breakthrough Infections

Summary: in this study, the poly vaccination of military personnel prior to deployment will be analyzed in terms of central, peripheral and long-lasting changes in innate immunity. analysis of monocyte immune training induced by vaccination will provide a better understanding of the indirect effects of vaccination and their persistence over time.


Eligibility criteria:
inclusion criteria: * french military personnel * \>18yo * overseas deployment scheduled between 30 and 60 days after vaccination session * adult * able to give consent exclusion criteria: * unrectified military personnel * having received a live vaccine within 6 months prior to inclusion * having received an attenuated vaccine within 3 months prior to inclusion * pregnancy or breastfeeding * vaccine contraindication * major incapacity
"effect of scaling and root planing on liver function test (alanine aminotransferase and aspartate aminotransferase) in systemically healthy - chronic periodontitis subjects: a clinical trial."

Conditions: Chronic Periodontitis (CP) Subjects.

Summary: aim: to evaluate effect of non- surgical periodontal therapy on liver function in systemically healthy chronic periodontitis (cp) subjects. materials and methods: the study is non surgical interventional trial, includes 50 cp subjects in the age group of 35- 60 years selected from the opd (out patient department) of department of periodontology tatyasaheb kore dental college and research center (tkdc and rc), kolhapur. cp subjects were equally divided into test group and control group. liver function test- aspartate aminotransferase (ast), alanine aminotransferase (alt) were checked at baseline and at 1 month after treatment. clinical examination includes plaque index, gingival index, sulcus bleeding index, probing depth, clinical attachment loss.


Eligibility criteria:
inclusion criteria: 1. subjects with cp (moderate and severe) as per centers for disease control and prevention (cdc) criteria 2007. 2. patients without any known systemic diseases - exclusion criteria: 1. patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study. 2. subjects who have undergone periodontal treatment within six months of inception of study. 3. smokers, tobacco habits in any form and alcoholics. 4. pregnant and lactating women. -
placental cord drainage after vaginal delivery

Conditions: Blood Loss

Summary: placental cord drainage after vaginal delivery a randomized clinical trial


Eligibility criteria:
inclusion criteria: * singleton pregnancy. * pregnancy with vertex presentation. * gestational age37 up to 42 weeks * patient expected to have spontaneous vaginal delivery. * maternal age 18 years old or more. exclusion criteria: * previous history of postpartum hemorrhage. * antepartum hemorrhage * multiple pregnancies * instrumental deliveries * coagulation disorders * over distended uterus (hydramnios, large fetus). * patient with extensive extended vaginal or cervical tear. * rupture uterus. * secondary arrest of cervical dilatation. * persistent occipito-posterior. * deep transverse arrest of fetal head.
study of autologous t-cells genetically modified at the ccr5 gene by zinc finger nucleases in hiv-infected subjects

Conditions: HIV; HIV Infection

Summary: this research study is being carried out to study a new way to possibly treat human immunodeficiency virus (hiv). the agent is called sb-728-t which are cd4+ t-cells obtained from an individual that are genetically modified at the ccr5 gene by zinc finger nucleases. the ccr5 gene is required for certain types of hiv to enter into and infect t-cells. t cells are one of the white blood cells used by the body to fight hiv. the most important of these are called "cd4+ t-cells" some people are born without the ccr5 gene on their t-cells. these people remain healthy and are resistant to infection with hiv. other people have a low number of ccr5 genes on their t-cells and their hiv disease is less severe and is slower to cause disease (aids). the purpose of this research study is to find out whether sb-728-t is safe to give to humans and find out how this affects hiv.

laboratory studies have shown that when cd4+ t-cells are modified with zinc finger nucleases sb-728, hiv is prevented from killing the cd4+ t-cells. on the basis of these laboratory results, there is the potential that this may work in humans infected with hiv and improve their immune system by allowing their cd4+ t-cells to survive longer. the new treatment to be studied will involve removing white blood cells from the blood that contain cd4+ t-cells. the extracted cd4+ t-cells are then genetically modified by the zinc finger nucleases to be resistant to infection by removing the ccr5 gene from the surface of the cd4+ t-cell where hiv enters the cell. additional genetically modified cells are manufactured and then re-infused back into the individual. researchers hope that these genetically modified cells will be resistant to infection by hiv and will be able to reproduce additional resistant cd4+ t-cells in your body.

Eligibility criteria:
inclusion criteria: * documented hiv infection * cd4+ t-cell count \>500 cell per millimeter cubed (cells/mm3) * cd4+ t-cell nadir of \>400 cells/mm3 * hiv viral load \>1,000 copies per milliliter (ml) exclusion criteria: * any viral hepatitis * acute hiv infection * hiv viral load \>1,000,000 copies/ml * active or recent (prior 6 months) aids defining complication * any hiv medications within the past 12 weeks * cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin * current diagnosis of nyha grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias * history of bleeding problems * use of chronic steroids in past 30 days * pregnant or breast feeding * active drug or alcohol abuse * serious illness in past 30 days * currently participating in another clinical trail or any prior gene therapy

Keywords: hiv
a study of nipocalimab in participants with active idiopathic inflammatory myopathies

Conditions: Myositis

Summary: the purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (iim).


Eligibility criteria:
inclusion criteria: * disease classification criteria: participant meets the diagnostic criteria of probable or definite idiopathic inflammatory myopathies (iim) based on 2017 the european league against rheumatism (eular)/american college of rheumatology (acr) classification criteria for adult iim at least 6 weeks prior to first administration of the study intervention * if a participant is on regular or as needed treatment with low potency topical glucocorticoids (gc) that are allowed in the study or topical tacrolimus (tac) to treat skin lesions, the dose and frequency should be stable for greater than or equal to (\>=) 4 weeks prior to first administration of the study intervention as well as maintained at the same dose until week 52 of the study * antibody positivity criteria: any 1 of the myositis-specific antibodies (msas) positive: dermatomyositis (dm): anti-mi-2 (mi-2/nucleosome remodeling and deacetylase \[nurd\] complex), anti-transcription intermediary factor 1-gamma (tif1-gamma), anti- nuclear matrix protein 2 (nxp-2), anti-small ubiquitin-like modifier-1 activating enzyme; anti- antimelanoma differentiation-associated gene 5 (mda-5) antibodies. or immune-mediated necrotizing myopathy (imnm): anti- signal recognition particle (srp) and anti- 3-hydroxy-3-methylglutaryl-coenzyme a reductase (hmgcr) antibodies. or anti-synthetase syndrome (asys): anti- histidyl- ribonucleic acid \[trna\] synthetase (jo-1), anti- threonyl-trna synthetase (pl7), anti- alanyl-trna synthetase (pl12), anti- isoleucyl-trna synthetase (oj), and anti- glycyl-trna synthetase (ej) antibodies. if all msas are negative or more than 1 msa is positive within different subtypes (defined by the central laboratory) at screening, the tests should be repeated during the screening period. if the same results are observed at retesting, the participant should not be enrolled in the study exclusion criteria: * has a juvenile myositis diagnosis and now \>=18 years old * has cancer-associated myositis defined as cancer diagnosis within 3 years of myositis diagnosis except for cervical carcinoma in situ and non-melanoma skin cancer (squamous cell carcinoma, basal cell carcinoma of the skin) * has comorbidities (example, asthma, chronic obstructive pulmonary disease \[copd\]) which have required 3 or more courses of oral gc within 1 year prior to screening * has a history of primary immunodeficiency or secondary immunodeficiency not related to the treatment of the participants iim * has experienced myocardial infarction (mi), unstable ischemic heart disease, or stroke within 12 weeks of screening
intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: the purpose of this study is to evaluate the role, the safety and the effectiveness of intravitreal bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * vitreous haemorrhage * tractional retinal detachment * active proliferative diabetic retinopathy. exclusion criteria: * neovascular glaucoma * cataract * combined traction and rhegmatogenous rd
health improvement project - providence

Conditions: HIV

Summary: this study will investigate whether phone-delivered mindfulness training is feasible and acceptable for persons living with hiv and whether it may help them improve adherence to medications and reduce risky sexual behaviors.

two-thirds of people living with hiv show sub-optimal adherence to antiretroviral therapy (art) and one-third engages in risky sex. both non-adherence and risky sex have been associated with emotional distress and impulsivity. in this trial, the investigators will examine the utility of phone-delivered mindfulness training (mt) for people living with hiv. the primary outcomes comprise feasibility and acceptability of phone-delivery; secondary outcomes are estimates of efficacy of mt on adherence to art and safer sexual practices as well as on their hypothesized antecedents. fifty participants will be enrolled in this parallel-group randomized clinical trial (rct). outpatients recruited from an hiv treatment clinic will be randomized (1:1 ratio) to either mt or to health coaching intervention; both interventions will be administered during 8 weekly phone calls. art adherence (self-reported measure and unannounced phone pill counts), sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.

Eligibility criteria:
inclusion criteria: * hiv infection * sub-optimal adherence to art (less than "always" taking art medication and/or viral load \> 20 copies/ml); * psychological distress (phq-4 score ≥ 2); * recent risky sexual behavior (any unprotected sex or \> 1 sexual partner over the past 6 months) * access to a telephone or cell phone exclusion criteria: * unwilling or unable to provide informed consent * cognitive impairment * non-english speaking * low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them * enrolled in another behavioral trials * prior formal mindfulness training or have practiced of mindfulness or related mind-body techniques in the previous year * severe hearing impairment not allowing phone delivery * suicidal ideation * planning to move out of the area within the study period * clinic provider advising against recruitment in the study.

Keywords: hiv mindfulness adherence behaviors stress depression
evaluation of a mindfulness intervention to prevent chemo-brain in women preparing for chemotherapy for breast cancer

Conditions: Breast Carcinoma

Summary: this clinical trial tests how well a mindfulness intervention helps the prevention of chemotherapy-brain (chemo-brain) in women preparing for chemotherapy for breast cancer. cognitive dysfunction after chemotherapy has been well-documented. factors that have been used to document and/or have been correlated with chemo brain include self-report and structural brain changes including volume loss. mindfulness is a type of meditation practice that can be learned to support well-being and decrease stress. mindfulness is an approach that helps the person increase their awareness of the present moment without judgement. there are data that mindfulness may increase attention and concentration which may prevent some of the side effects from chemotherapy

primary objectives: i. assess the feasibility of an 8-week mindfulness intervention in women preparing for chemotherapy for breast cancer. ii. evaluate cognitive dysfunction related factors as an exploratory objective: cognitive function, quality of life, inflammatory markers, functional magnetic resonance imaging (fmri) brain imaging, and a record of mindfulness practice. outline: patients participate in a mindfulness program composed of topics that include mindfulness of breathing and the body scan, mindful eating, mindful activity, mindfulness in daily life, expanding the field of awareness, and maintaining a flexible mindfulness practice weekly over 2.5 hours for 8 weeks. patients also undergo blood sample collection and fmri on the study. after completion of study intervention, patients are followed up at 3 months.

Eligibility criteria:
inclusion criteria: * 18 years or older * breast cancer diagnosis preparing to undergo chemotherapy exclusion criteria: * under the age of 18 * cannot provide informed consent
computerized questionnaires in assessing symptoms, pain, depression, and physical function in patients with metastatic and/or advanced locoregional cancer

Conditions: Cachexia; Depression; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: a computer-based system for assessing symptoms may be effective for patients with metastatic or advanced cancer. purpose: this clinical trial is studying how well computerized questionnaires work in assessing symptoms, pain, depression, and physical function in patients with metastatic and/or advanced local/regional cancer.

objectives: * determine the feasibility of applying a computer-based system for symptom assessment and classification in palliative cancer care in patients with metastatic and/or advanced cancer. * examine hypothesized differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.). * examine the general user-friendliness of the tool. * test and validate the performance of selected domains and items for classification and assessment of pain and cachexia. * explore the validity of domains and items for depression. outline: this is a multicenter study. all patients undergo computer-based assessments of general symptoms by the edmonton symptom assessment system (esas) and the european organization for research and treatment of cancer core quality of life (eortc qlq c30) questionnaires and assessment of physical function, appetite/weight loss, and depression by the brief patient health questionnaire 9 (prime-md phq9). patients who score ≥ 1 (on a 0-10 numerical rating score) on the pain screening question with or without occurrence of breakthrough pain (btp), undergo the alberta btp assessment tool assessing precipitating factors for pain, time to pain relief after intake of medication, and satisfaction with medication. patients complete questions regarding user-friendliness and feasibility of using the computer at the end of their session.

Eligibility criteria:
disease characteristics: * diagnosis of incurable cancer, including patients receiving life-prolonging treatment * metastatic and/or advanced locoregional disease patient characteristics: * able to provide written informed consent * fluent in the language used at the study site prior concurrent therapy: * no prior inclusion in this study

Keywords: depression cachexia pain unspecified adult solid tumor, protocol specific
targeted translocator protein pet imaging evaluate neuroinflammation of the chronic pain patients

Conditions: Chroinc Pain; PET; Microglial Activation

Summary: chronic pain is a major public health issue, which seriously affects patients' quality of life. neuroinflammation is an important mechanism resulting in chronic pain. translocator protein (tspo) has served as a marker of microglial activation and neuroinflammation. 18f-dpa714, a tracer targeted tspo, can be used to evaluate the microglial activation and neuroinflammation in vivo by pet imaging.recent and increasing studies have found changes in tspo and its ligands in various chronic pain models. reversing their expressions has been shown to alleviate chronic pain in these models, illustrating the effects of tspo and its ligands.the investigators aim to explore the clinical feasibility used 18f-dpa714 pet imaging to monitor microglial cells activation of center nervous system in chronic pain patients. this study might reveal significant neuroinflammatory process in the center nervous system of the chronic pain patients. the results of this study might provide a new biomarker of disease pathological progression and indicates that tspo-based therapy may become an alternative strategy for treating chronic pain.


Eligibility criteria:
inclusion criteria: * chronic pain patients * written informed consent was provided by the patients and their family exclusion criteria: * history of head trauma ， epilepsy， claustrophobia, rheumatic or autoimmune diseases, psychiatric disorders, severe somatic diseases (neurological,cardiovascular, etc.),previous heart or brain surgery, substance abuse, inability to refrain from hypnotics, magnetic implants, pregnancy, lactation
management of placenta previa cases and determination of hospitalization criteria

Conditions: Placenta Previa

Summary: placenta previa cases are one of the difficult groups of patients to manage in modern obstetrics. when the literature is evaluated extensively, no clear information can be seen especially in terms of hospitalization time. inpatient follow-up of this patients has negative effects like hospital infections in terms of the patient, workload in terms of health personnel and financial losses in terms of the country's economy. placenta previa cases are complicated patients in which generalizations cannot be easily performed and they should be monitored at third level hospitals. in addition, care should be personalized considering the many reasons. in this study, placenta previa cases will be followed up at 28th gestational week and evaluated at 32nd week by vaginal ultrasonography and mri and this follow-up will continue until delivery. thus, in this study, it was aimed to determine the parameters that would allow systematic personalization of health service in this particular patient group by making risk assessment of placenta previa cases.


Eligibility criteria:
inclusion criteria: * monitoring of placenta previa * to apply before the 28th week * to have a low-risk second trimester screening test * no malformation detected in the anomaly screening exclusion criteria: * multiple pregnancies * pregnancy complicated with preeclampsia * pregnancy complicated by gestational hypertension * pregnancy complicated by gestational diabetes mellitus

Keywords: placenta previa placental invasion anomalies timing of the birth